Inkine Pharmaceutical (NASDAQ:INKP)
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InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today
announced that seven abstracts with data from clinical studies of the
Company's next-generation purgative product, INKP-102, have been
accepted for poster presentations at the 70th Annual Scientific
Meeting of the American College of Gastroenterology (ACG), to be held
from October 28 to November 2, 2005, at the Honolulu Convention
Center.
The abstracts are based on the results of two randomized,
multicenter, investigator-blinded clinical trials comparing various
dosing regimens of INKP-102 to 40 Visicol(R) tablets in adults
undergoing colonoscopy, including a Phase 2 dose-ranging trial and a
Phase 3 pivotal trial. These trials indicate that INKP-102 may have
important advantages over Visicol(R) tablets in efficacy, safety, and
acceptance by patients. Visicol(R) is the Company's currently marketed
sodium phosphate tablet purgative, which is indicated for cleansing of
the bowel as a preparation for colonoscopy in adults 18 years of age
or older. INKP-102 tablets contain the same active ingredients as
Visicol(R), but are smaller in size and easier to swallow. Also, the
new tablets contain no microcrystalline cellulose (MCC), an inert, but
highly insoluble, tablet binder that is present in Visicol(R). The
Company has filed patent applications that, if granted, would protect
INKP-102 until 2024.
The seven abstracts are authored by a total of 20 academic and
community gastroenterologists and colorectal surgeons who were study
investigators, as well as by Company scientists. The abstracts present
a broad range of data relating to the efficacy, safety and patient
acceptance of INKP-102 tablets, including:
-- Efficacy results of the Phase 2 dose ranging study, suggesting
that several of six tested dosing regimens of INKP-102,
including regimens of 28, 32, or 40 tablets, provided colon
cleansing at least comparable to or better than marketed
Visicol(R) tablets;
-- Efficacy results of the Phase 3 pivotal trial, indicating that
32 or 40 INKP-102 tablets provided overall colon cleansing at
least comparable to Visicol(R), with significantly better
cleansing in the ascending colon;
-- Additional efficacy results of the Phase 3 trial, indicating
that INKP-102 tablets provided excellent colon cleansing for
both morning and afternoon colonoscopy procedures;
-- Results from the Phase 3 study indicating that patients found
32 INKP-102 tablets to be easier to take and preferable for a
future colonoscopy than 40 Visicol(R) tablets;
-- Results from the combined data of the Phase 2 and Phase 3
studies indicating that the safety and efficacy of INKP-102
tablets were similar in patients 65 and older compared to
younger patients;
-- Safety results from the combined data of the two studies
indicating that 32 INKP-102 tablets were associated with a
significantly lower rate of adverse events than 40 Visicol(R)
tablets; and
-- Results from the combined safety database indicating that 32
INKP-102 tablets were associated with a better electrolyte
profile than 40 Visicol(R) tablets.
The accepted abstracts will be published in an upcoming edition of
the American Journal of Gastroenterology.
"The upcoming ACG meeting will be the first forum where the
gastroenterology community is exposed to the outstanding results of
our two completed trials of INKP-102," said Robyn G. Karlstadt, M.D.,
F.A.C.G., InKine's Vice President for Clinical Operations. "We believe
that these studies, conducted in over 1,000 patients, are consistent
in demonstrating the excellent colon cleansing of 32 tablets of
INKP-102 throughout the colon in adults of all ages, regardless of the
time of day the colonoscopy was performed. The studies also indicate
that the 32 tablet dose of INKP-102 has a better safety profile than
40 Visicol(R) tablets and is consistently preferred by patients,"
added Dr. Karlstadt.
"The results of our two studies of INKP-102 indicate that we have
made a very good purgative, Visicol(R) tablets, even better," stated
Martin Rose, M.D., J.D., InKine Executive Vice President for Research
and Development. "We believe that the data show that our next
generation purgative provides comparable or better colon cleansing
than Visicol(R) at a lower total dose of sodium phosphate, with
enhanced safety and patient acceptance. We think that physicians who
have already switched to Visicol(R) will find that they and their
patients will like INKP-102 even more. Those physicians who have tried
Visicol(R) and found the MCC residue to be bothersome ought to be very
pleased by the improved cleansing of INKP-102, especially in the cecum
and ascending colon. All physicians should appreciate the improved
safety of the lower dose, and patients will like the smaller tablet,"
added Dr. Rose.
InKine submitted a New Drug Application (NDA) during the second
quarter of 2005 for US marketing of INKP-102. The US Food and Drug
Administration (FDA) recently informed InKine that the NDA was
accepted for filing and will be reviewed.
The Company anticipates that the commercial launch of INKP-102
will occur in the first half of 2006. However, there can be no
assurance INKP-102 will receive FDA approval. Without FDA approval,
the Company cannot market or sell INKP-102.
About InKine Pharmaceutical
InKine Pharmaceutical Company, Inc. is a publicly traded specialty
pharmaceutical company focused on developing and commercializing
pharmaceutical products for the diagnosis and treatment of
gastrointestinal disorders. The Company's development strategy has
been to acquire late-stage drug candidates with short time lines to
commercialization. The Company's franchise product, Visicol(R) is the
only tablet purgative preparation indicated for bowel cleansing prior
to colonoscopy. InKine's second product, IB-Stat(R), is an oral
hyoscyamine spray for the treatment of a variety of indications.
Additionally, the Company is developing INKP-102, an advanced
generation purgative, which we recently submitted a new drug
application to FDA for bowel cleansing prior to colonoscopy and
developing Visicol(R) for use as a laxative in treating patients with
chronic constipation. For further information, please visit InKine on
its web site http://www.inkine.com.
This press release contains forward-looking statements, including
statements regarding our expectations regarding INKP-102, including
the potential benefits of INKP-102, the timing of commercial launch of
INKP-102 and expectations of physician and patient acceptance of
INKP-102. Such forward-looking statements are based on InKine's
current expectations or forecasts of future events. InKine's
performance and financial results could differ materially from those
reflected in these forward-looking statements due to general
financial, economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries, InKine's ability to
commercialize INKP-102 and grow product revenue and the effects of the
other risks and uncertainties set forth in InKine's reports on Form
10-Q and 10-K filed with the U.S. Securities and Exchange Commission.
Given these risks and uncertainties, any or all of these
forward-looking statements may prove to be incorrect. Therefore, you
should not rely on any such factors or forward-looking statements.
Furthermore, InKine may elect to update forward-looking statements,
but the Company disclaims any obligation to do so.